AMAM - Ambrx Biopharma's breast cancer candidate achieves positive results
An interim analysis for ACE-Breast-02, a Phase 3 breast cancer clinical trial conducted by Ambrx Biopharma's ( NYSE: AMAM ) partner NovoCodex Biopharmaceuticals has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control.
ACE-Breast-02 is a Phase 3 clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in the treatment of HER2+ patients with locally advanced or metastatic breast cancers in China.
The trial enrolled 441 HER2+ breast cancer patients who have been previously treated with taxane and trastuzumab.
Based on the results, NovoCodex plans to submit a communication application seeking marketing approval in China.
The FDA has granted Fast Track Designation for ARX788 in HER2+ metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer.
Shares down 3.1% premarktet.
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Ambrx Biopharma's breast cancer candidate achieves positive results